BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P080027 · Supplement: S017 · Decision Sep 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    ORAQUICK HCV RAPID ANTIBODY TEST
    PMA Number
    P080027
    Supplement Number
    S017
    Device Class
    FDA Class 2
    Product Code
    MZO
    Generic Name
    Assay, enzyme linked immunosorbent, hepatitis c virus
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 2, 2014
    Date Received
    June 6, 2014
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE EXPIRATION DATING FOR THE ORAQUICK® HCV VISUAL REFERENCE PANEL TO A FIVE MONTH EXPIRATION DATE FOR POUCHED AND UN-POUCHED DEVICES THAT ARE PROTECTED FROM LIGHT AND 15 DAYS FOR DEVICES THAT ARE NOT PROTECTED FROM LIGHT.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus